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Open Label Evaluation of H5N1 Vaccine at Vaccine Manufacturing Facilities

2014-08-27 03:45:21 | BioPortfolio

Summary

The purpose of this research is to study side effects and safety of a new H5N1 flu (bird flu) vaccine and to look at how well people's immune systems make antibodies to fight infection after they get the vaccine. Up to 300 healthy people who are working at Aventis Pasteur H5N1 virus vaccine production facility in Swiftwater, PA, during the flu season are being asked to participate. It is important for vaccine production workers to receive the vaccine in order to minimize the risk of this bird flu virus combining with the regular flu virus. Volunteers in this study will have a medical screening, 2 vaccinations a month apart, 2 blood sample collections (1 before and 1 after the vaccinations to compare), 5 clinic visits, and follow-up over 6 months. They will also complete a diary card and to write down their temperature once a day and any symptoms they have every day during the week after they get their second shot. They will also be asked to write down any drugs or medicines they take.

Description

The primary goal of this phase I/II, single center, open label study is to obtain additional safety and immunogenicity data on two 90 µg doses of H5N1. It is anticipated that this dose level will result in an acceptable proportion of subjects achieving a potentially protective postvaccination antibody titer combined with an acceptable safety profile. The purpose of the current study is to induce maximal anti-H5N1 titers as quickly as possible in order to protect at-risk personnel manufacturing a commercial-scale H5N1 vaccine under contract to the United States government. The study will be performed under the direction of investigators at the University of Maryland School of Medicine's Center for Vaccine Development. Volunteers will be enrolled, vaccinated, and followed at Sanofi Pasteur, in Swiftwater, PA. Up to 300 healthy vaccine production worker volunteers, aged 18 years and older, will receive 90 mcg of the influenza A/H5N1 vaccine by intramuscular injection. Volunteers will receive 2 doses of the vaccine separated by approximately 28 days. Serum HAI and neutralizing antibody titers will be assessed approximately 1 month after the second vaccine dose. Volunteers will be observed in the clinic for at least 15 minutes after each vaccination, and they will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for seven days after each immunization. Volunteers will return to the clinic on Day 7 for AE and concomitant medication assessment, a targeted physical examination (if indicated), and review of the memory aid. Serum for immunogenicity evaluations will be obtained prior to the first vaccination (Day 0) and on Day 56. Primary study objectives are to: (1) determine the safety of subvirion inactivated A/H5N1 vaccine in healthy vaccine production workers adults; and (2) determine the immunogenicity of subvirion inactivated H5N1 vaccine in healthy adults approximately 1 month following receipt of two 90 mcg doses of vaccine. Primary study endpoints are: (1) adverse event (AE) or serious adverse event information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment); (2) geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers at two months after receipt of the first dose of vaccine; (3) GMT and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers at 2 months after receipt of the first dose of vaccine; and (4) proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine (approximately Day 56).

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Influenza

Intervention

Inactivated Influenza A Vaccine A/H5N1 (sanofi pasteur)

Location

Sanofi Pasteur
Swiftwater
Pennsylvania
United States
18370

Status

Completed

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:21-0400

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Medical and Biotech [MESH] Definitions

A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 5 and neuraminidase 1. The H5N1 subtype, frequently referred to as the bird flu virus, is endemic in wild birds and very contagious among both domestic (POULTRY) and wild birds. It does not usually infect humans, but some cases have been reported.

Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.

Membrane glycoproteins from influenza viruses which are involved in hemagglutination, virus attachment, and envelope fusion. Fourteen distinct subtypes of HA glycoproteins and nine of NA glycoproteins have been identified from INFLUENZA A VIRUS; no subtypes have been identified for Influenza B or Influenza C viruses.

Infection of domestic and wild fowl and other BIRDS with INFLUENZA A VIRUS. Avian influenza usually does not sicken birds, but can be highly pathogenic and fatal in domestic POULTRY.

Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.

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